Sr. Scientist, Biomaterials R&D Full-time

Sr. Engineer, Material/Bio Science

DePuy Synthes is recruiting for a Sr. Engineer, Material/Bio Science, located in US248 PA WEST CHESTER – 1302 WRIGHTS LN E Designs and develops new biomaterials technologies and/or supports in-market products through their product life-cycle within multiple cross-functional project teams. Performs prototyping and testing of innovative materials technologies, develops new test methods and manufacturing processes, and supports regulatory submissions. This includes communication with other R&D Scientists and Engineers, Marketing and Sales consultants, and customers e.g., Health Care Professionals. The Senior R&D Scientist will be an integral resource to the R&D team, providing technical expertise on materials science, chemistry, and test methods.

Section 2: Duties & Responsibilities *

• Act as a technical team member of a cross-functional project core team (marketing, manufacturing, quality, testing, supply chain, regulatory, etc.).
• Coordinates with design engineers, marketing, quality, supply chain, manufacturing, regulatory affairs, and other functional departments to develop and test new product concepts.
• Independently develop testing protocols using laboratory instruments, following standard methods or designing custom methods.
• Performs and/or coordinates laboratory tasks in a safe manner in analytical, chemical, polymer R&D labs.
• Development and execution of design verification and validation plans and activities, and test plan formation and execution to support global regulatory strategy.
• Supports development of intellectual property for novel designs.
• Collaborate with supply chain, manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation.
• Designs and executes or coordinates scientific experiments, present data and conclusions with appropriate analysis and writes technical reports.
• Demonstrate proficiency in the application of statistical methods for test method development and verification and validation activities.
• Understands and follows the New Product Development process accurately and maintains high quality design validation and verifications.
• May be responsible for operating within a budget and provide input on budget allocation and prioritization.
• Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed

Section 3: Experience and Education *

• A minimum of six years of experience in the development or testing of biomaterials and biologics based medical devices, drug products, or combination products.
• MS in Chemistry, Materials Science, or equivalent required. A PhD degree is preferred.
• Experience working in medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements is preferred.

Section 4: Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations *

• Knowledge of biomaterial technologies and chemical test methods is required
• Strong communication skills – The ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers, e.g., Health Care Professionals and/or teams across the organization is required. Ability to work effectively as a technical leader and sometimes as a project leader.
• Possess strong organizational skills to support all aspects of the project management functions including scope definition, budgeting, and contingency planning.
• Excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations is required.
• Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience.
• Must have the ability to effectively communicate concepts, ideas and knowledge to other individuals, Health Care Professionals, customers and/or teams, and work effectively as a technical leader and sometimes as a project leader.
• The ability to review and critically assess patents and other forms of intellectual property is preferred.
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) is required.